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CompletedNCT03331458PACMenUpdated Aug 26, 2019

Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

An interventional study of exrecise intervention in Prostate Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-26.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 49 studies in Prostatic Neoplasms by Duke University — 4 open to participants now, 5 under way, none of them phase 3. Prostatic Neoplasms · Duke University.

Enrollment
26th of 34
13 · median 35
Started
2018
with 1 other
No phase
18 of 49
1 open now
Registered
37th of 49
by date

Among the 49 studies in Prostatic Neoplasms by Duke University, this one is the 26th largest by enrollment of the 34 interventional ones that give a count, is one of 2 that started in 2018, is one of 18 with no phase, and was the 37th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

4 of the 49 studies in Prostatic Neoplasms by Duke University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

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02

Study summary

Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.

The purpose of this study is to

  1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
  2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

    1. Examine intervention safety and tolerance by self-report
    2. Examine changes in functional capacity by 6-minute walk test
    3. Examine changes in symptom experience by self-report
03

Conditions studied

  • Prostate Cancer

Keywords

  • physical activity
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newly diagnosed with prostate cancer
  • will not start treatment for at least 2 weeks
  • able to read and understand English
  • capable of giving
  • at least 18 years old

Exclusion criteria

Exclusion Criteria:

  • patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
  • unable to provide as assessed by the interviewer
  • too sick to participate, as judged by a member of the research team or the exercise physiologist
  • have been treated for another cancer
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    subjects with prostate cancer

    Behavioral: exrecise intervention

Interventions

  • Behavioralexrecise intervention

    Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures

06

What researchers measure

Primary outcomes

  1. Change in 6 minute walk test

    Distance walked in 6 minutes

    Time frame: baseline, 2 weeks post intervention

  2. Change in balance test

    Ability to balance

    Time frame: baseline, 2 weeks post intervention

  3. Change in time up to go test

    Time to get up from chair, walk 30 meters and return to sit in chair

    Time frame: baseline, 2 weeks post intervention

  4. Change in Godin Leisure Time Score

    physical activity score

    Time frame: baseline, 2 weeks post intervention

  5. Change in rate of perceived exertion

    physical exertion score

    Time frame: baseline, 2 weeks post intervention

  6. Change in metabolic equivalent

    metabolic activity score

    Time frame: baseline, 2 weeks post intervention

  7. Change in distress score

    distress score

    Time frame: baseline, 2 weeks post intervention

  8. Change in self-efficacy score

    self-efficacy score

    Time frame: baseline, 2 weeks post intervention

  9. Change in symptom inventory score

    description of symptoms

    Time frame: baseline, 2 weeks post intervention

07

Study locations

1 site
  • Duke Raleigh Cancer Center
    Raleigh, North Carolina 27606, United States
08

References and documents

Individual participant data

Plan to share: No — No plan to share feasibility study data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Mar 2019, 11 months.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's 11 months is below that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 6, 2017
StartActual
Apr 17, 2018
Primary completionActual
Mar 21, 2019
CompletionActual
Mar 21, 2019
Last update
Aug 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03331458
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Apr 17, 2018
Primary completion
Mar 21, 2019
Completion
Mar 21, 2019
Last update
Aug 26, 2019

Study contacts

Deborah Allen
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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